2024-513405-31-00招募中2 期
A Phase 2 multicenter, randomized, placebo controlled, double-blind study to assess the safety and efficacy of CC-486 (oral azacitidine) in combination with pembrolizumab (MK-3475) versus pembrolizumab plus placebo in subjects with previously treated locally advanced or metastatic non-small cell lung cancer
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- PFS measured as time from randomization to progression according to RECIST 1.1 (based on Investigator assessment)
研究概览
简要总结
To estimate the efficacy of CC-486 plus pembrolizumab versus pembrolizumab plus placebo based on PFS as measured using RECIST 1.1 criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Randomized, placebo controlled, double-blind study
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years of age at the time of signing the informed consent form.
- •Subject has histologically or cytologically confirmed squamous or nonsquamous NSCLC.
- •Subject has stage IIIB or IV NSCLC and was pretreated with only 1 prior systemic platinum based chemotherapy.
- •Subject has provided a formalin fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of metastatic disease has been made AND from a site not previously irradiated to assess for PD-L1 status.
- •Subject has radiographically-documented measurable disease, as per RECIST 1.
- •Subject has an ECOG performance status of 0 to
- •Subject has adequate organ and bone marrow functions
排除标准
- •Subject with non-squamous histology has known or unknown sensitizing EGFR and/or positive ALK mutation Note: Subjects with squamous histology and unknown EGFR and ALK mutational status are eligible.
- •Subject has received more than one line of therapy for stage IIIB or IV disease.
- •Subject has received prior therapy with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanism
- •Subject has had radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting IP, and/or from whom ≥ 30% of the bone marrow was irradiated.
- •Subject has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted
- •Subject has active autoimmune disease that has required systemic treatment within the past 2 years
- •Subject with uncontrolled or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. *Subjects with controlled and asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases (must include radiotherapy and/or surgery) >= 28 days (>= 14 days for stereotactic radiosurgery). Patients must not be receiving corticosteroids for brain metastases.
结局指标
主要结局
PFS measured as time from randomization to progression according to RECIST 1.1 (based on Investigator assessment)
PFS measured as time from randomization to progression according to RECIST 1.1 (based on Investigator assessment)
次要结局
- Number (%) of subj. with SD for ≥ 18 weeks, complete response (CR) or PR (DCR).
- Overall survival.
- Number (%) of subj. who achieve an objective CR or PR (ORR).
- Safety to include the incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, Grade 3-4 TEAEs, TEAEs of special interest, and laboratory abnormalities and other safety parameters.
- Plasma PK parameters such as maximum observed concentration (Cmax), area under the concentration-time curve (AUC), time to maximum concentration (Tmax), terminal half-life (t1/2), apparent total body clearance (CL/F) and apparent volume of distribution (Vz/F) for CC-486.
研究者
GSM-CT
Scientific
Celgene Corp.
研究点 (1)
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